Immunomodulatory Effects of Dexmedetomidine Infusion

Not Applicable

• Conditions: Major Abdominal Surgery
• Interventions: Drug: 0.9% sodium chloride; Drug: Dexmedetomidine

• Registration Number: NCT04923737
• Lead Sponsor: Alexandria University

Brief Summary

Anesthetic management may affect both immunostimulatory and immunosuppressive mechanisms directly by modulating immune cell function or indirectly by attenuating the stress response, Thus, the choice of anesthetic technique may affect clinical outcomes by perturbing the balance between pro- and anti-inflammatory responses,anesthetics favoring this delicate balance are thus desirable as their use may reduce postoperative complications and mortality

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-06-07
• Study First Submitted QC: 2021-06-07
• Study First Posted: 2021-06-11
• Study Start: 2022-01-01
• Status Verified: 2022-05
• Primary Completion: 2022-05
• Study Completion: 2022-05
• Last Update Submitted: 2022-05-29
• Last Update Posted: 2022-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• scheduled for elective laparoscopic major abdominal surgeries;
• ASA class II-III

Exclusion Criteria

• 1- Patients with severe infection or diseases in respiratory system 2- Patients with severe arrhythmia or bradycardia 3- Patients with severe diseases in liver, kidney, endocrine or immune system. 4- Patients with history of uncontrolled hypertension, A-V conduction block. 5- Patients who had administrated the α-adrenergic agonists or β-receptor antagonist.

6- Patients who received the chemotherapy, radiotherapy, or immunotherapy within one month before operation 7- Patients who had feverbefore operation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	0.9% sodium chloride	patients will receive an equal volume of 0.9% sodium chloride (both the loading, and the infusion
Dexmedetomidine group	Dexmedetomidine	patients will receive a loading dose of IV Dexmedetomidine1μg/kg slowly just before induction of anesthesia, then Dexmedetomidine infusion started at a rate of 0.5μg/kg/h.

Primary Outcome Measures

Name	Time	Method
immune-modulatory effects	three days after surgery	serum concentrations of C-reactive protein (CRP) level ,The pro-inflammatory cytokines interleukin (IL)-1β, and IL-6 and anti-inflammatory cytokines IL-10 will be measured at four times: T0 (before anesthesia), T1 (1 h after surgery), T2 (24 h after surgery) and T4 (72 h after surgery

Trial Locations

Locations (1)

Rehab Abd Elraof Abd Elaziz; 🇪🇬 Alexandria, Egypt